Analyzing the Composition of Tears and Blood for Discover... | NCT01514669

Studies
Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer

NCT01514669

Sponsor

University of Arkansas

Status

Active, not recruiting

Last Update Posted

Oct 10, 2025Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jan 17, 2012

First Submission Date that Met QC Criteria

Jan 17, 2012

First Posted Date

Jan 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2025

Last Update Posted Date

Oct 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

75Estimated

Label	Type	Description	Intervention Names
No treatment		No Tx, this is observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tear Sample	Tear sample will be taken at the initial clinic visit	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male, 35-85 years old
Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.)
Patients who present for the evaluation of a palpable nodule or induration on prostate exam
Patients who meet the requirements of Group 1, 2, or 3 of the protocol

Exclusion Criteria:

Patient < 35 or > 85 years of age
Concurrent eye infection or trauma, including active conjunctivitis
Abnormal production of tears (too much or too little)
Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment
Atypia on prostate biopsy report

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Participants will be selected from those outpatients followed in the Winthrop P. Rockefeller Cancer Institute (located at the University of Arkansas for Medical Sciences).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Diekman, Ph.D.	University of Arkansas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided